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Trial Title:
PDO/PDO-TIL/PDOTS for Drug Screen
NCT ID:
NCT05913141
Condition:
Liver Cancer
Metastatic Liver Cancer
Conditions: Official terms:
Liver Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Other
Intervention name:
Drug screen with PDO/PDO-TIL/PDOTS
Description:
Drug screen with patient-derived organoids, patient-derived organoids-tumor-infiltrating
lymphocyte coculture system, or patient-derived organotypic tissue spheroids.
Arm group label:
Patients with PDO/PDO-TIL/PDOTS
Summary:
This clinical trial aims to use the patient-derived organoid (PDO), Patient-derived
organoids-tumor-infiltrating lymphocyte coculture system (PDO-TIL) and patient-derived
organotypic tissue spheroids (PDOTS) to simulate the tumor microenvironment in cancer
patients. The culture system can be used for pre-clinical validation of drugs and
screening of drugs to treat sensitive people and provide individualized treatment for
patients with liver cancer. This model is used to explore the molecular mechanism of drug
resistance and to find intervention strategies to further improve the response rate of
drugs. This study is expected to provide an ideal platform for drug screening and drug
resistance research in liver cancer patients, which can replace experimental animal
models, and guide personalized medication for liver cancer patients, so as to improve the
overall prognosis of patients.
Criteria for eligibility:
Study pop:
Liver cancer or metastatic liver cancer
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
1. ≥18 years old, male or female.
2. Liver cancer or metastatic liver cancer diagnosed clinically or pathologically, at
least one measurable lesion.
3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
4. Patient has given written informed consent.
5. The function of important organs meets the requirements.
6. Non-surgical sterilization or women of childbearing age need to use a
medically-accepted contraceptive (such as an intrauterine device, contraceptive or
condom) during the study period and within 3 months after the end of the study
treatment period.
Exclusion Criteria:
1. The patient has any active autoimmune disease or a history of autoimmune disease
(such as the following, but not limited to autoimmune hepatitis, interstitial
pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis,
nephritis, thyroid Hyperfunction; patients with vitiligo; complete remission of
asthma in childhood, can be included without any intervention after adulthood;
asthma patients who require bronchodilators for medical intervention cannot be
included).
2. The patient is using immunosuppressive agents or systemic hormonal therapy to
achieve immunosuppressive purposes (agents amount > 10 mg/day of prednisone or other
therapeutic hormones), and continue to use within 2 weeks before enrollment.
3. Have clinical symptoms or diseases that are not well controlled.
4. Significant clinically significant bleeding symptoms or a clear bleeding tendency
within 3 months prior to randomization.
5. Arterial/venous thrombosis in the first 6 months of randomization.
6. According to the investigator, the patient has other factors that may affect the
results of the study or lead to the termination of the study, such as alcohol abuse,
drug abuse, other serious diseases (including mental illness) requiring combined
treatment, and serious laboratory abnormalities.
Gender:
All
Minimum age:
18 Years
Maximum age:
90 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Zhongshan Hospital, Fudan University
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Contact:
Last name:
Bo Hu, Doctor
Phone:
+8613701897234
Email:
drbohu@163.com
Start date:
June 2023
Completion date:
June 2026
Lead sponsor:
Agency:
Shanghai Zhongshan Hospital
Agency class:
Other
Source:
Shanghai Zhongshan Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05913141
